Rhea Dapagliflozin

Rhea Dapagliflozin

Manufacturer:

AstraZeneca

Distributor:

Philusa
Concise Prescribing Info
Contents
Dapagliflozin (as propanediol monohydrate)
Indications/Uses
Adult w/ type 2 DM as adjunct to diet & exercise; prevention of new or worsening of heart failure (HF) or CV death; prevention of new or worsening of nephropathy. HF w/ reduced ejection fraction; CKD.
Dosage/Direction for Use
10 mg once daily. Type 2 DM 10 mg once daily as monotherapy or as add-on to combination therapy w/ metformin 500 mg once daily.
Administration
May be taken with or without food: Taken any time of the day
regardless of meals.
Special Precautions
Patients w/ predisposing factors to ketoacidosis including low β-cell function reserve resulting from pancreatic disorders (eg, type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction, reduced caloric intake or increased insulin requirements due to infections, illness or surgery & alcohol abuse. Discontinue or temporary interruption of treatment if ketoacidosis is suspected. Not indicated for treatment of patients w/ type 1 DM. Discontinue treatment if Fournier's gangrene is suspected. Concomitant use w/ medications known to cause hypoglycemia eg, insulin & insulin secretagogues (eg, sulfonylureas). Evaluate renal function prior to initiation of therapy & periodically thereafter. Severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD. Avoid during pregnancy (2nd & 3rd trimester). Lactation. Childn & adolescents.
Adverse Reactions
Genital infection, UTI; back pain; pollakiuria & polyuria.
Drug Interactions
Decreased systemic exposure w/ rifampicin. Increased systemic exposure w/ mefenamic acid. May lead to reduction in serum lithium conc due to possible increased urinary clearance of lithium. Interference w/ 1,5-anhydroglucitol assay.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BK01 - dapagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Form
Rhea Dapagliflozin FC tab 10 mg
Packing/Price
28's
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